On January 4, 2013, two years after the Food Safety Modernization Act (FSMA) was signed into law, FDA issued its proposed Hazard Analysis and Risk-Based Preventive Controls (HARPC) regulations. At the same time, FDA also put forward a provision that aims to revise the requirements for current Good Manufacturing Practices (cGMPs), the basic federal sanitation and prerequisite program guidelines that have not been significantly updated since 1986. Together, these draft rules place food plant sanitation solidly in the spotlight, giving food manufacturers a new impetus to evaluate and develop sanitation controls to boost their plants’ FSMA readiness well ahead of the final rules.

Preparation is key

Open for public comment through May 16, HARPC is a linchpin rule under FSMA that seeks to require an estimated 97,000 domestic and 109,200 foreign food manufacturing facilities to develop written food safety plans, implement preventive controls and maintain documentation in their processing plants. The proposed rule features elements similar to the previously implemented juice and seafood Hazard Analysis Critical Control Points (HACCP) rules. To develop the food safety plans, processors must evaluate microbiological, chemical and other hazards that are likely to occur in foods manufactured, handled, packaged or stored in each facility, and identify, validate and institute appropriate preventive controls to mitigate those hazards, such as sanitation, process or food allergen controls. Processors will also need to ensure corrective actions are in place, implement verification activities and develop recall plans. 
In addition, under the cGMP provision, protocols and procedures for food allergen and environmental pathogen controls, worker training and food-contact surface sanitation would become mandatory, rather than mere recommendations.
Larry Keener, president of Seattle-based International Product Safety Consultants, LLC, a consulting firm providing food safety and technology solutions to the global food processing industry, states that the most visible impact on the food plant’s sanitation and sanitation-related activities will be proof of efficacy. 
“In the past, it has been good enough to enter the food plant, conduct sanitation and cleaning activities, and if it looked and smelled good, it was good,” Keener says. “But there haven’t always been steps to confirm sanitation measures are indeed good, that a production line or facility was indeed acceptably clean to a microbiological level for the manufacture of food for human consumption.”
With the FSMA HARPC rule, Keener says, companies will have to prove, demonstrate and document the proof of efficacy of sanitation procedures and other preventive controls. “That’s the essence of preventive control: demonstrating a cause-and-effect relationship and then proving you have broken the nexus of the cause and effect, such that the result is safe food.” 
FSMA’s overarching goal is to strengthen the US food safety system to reduce the economic burden and public health costs associated with foodborne illness. In 2010, The Pew Charitable Trusts, in concert with the Produce Safety Project at Georgetown University, published a report estimating the total economic impact of foodborne illness in the US at around $152 billion each year. According to FDA, foods that would be regulated under FSMA are associated with nearly 1 million illnesses annually. Preventing those illnesses, states the agency, will result in an estimated savings of $2 billion per year. 
 Implementing HARPC and the cGMP modernization requirements is expected to have significant operational and economic impacts on food and beverage processing plants of all sizes. FDA’s estimated first-year cost to the food industry sectors regulated under HARPC is about $701 million, with an estimated ongoing annual compliance cost of $472 million. The projected costs, which FDA estimates will be $1,000 to $25,000 per facility, include spending to create and implement the food safety plans, personnel training, supplier auditing and monitoring programs, as well as capital investments in facility, equipment and preventive controls technologies and documentation systems. 
The real costs to the industry of implementing HARPC and the cGMP provision is probably underestimated, but that should not be a deterrent to being proactive, states Jerry Roberts, president, Global Quality and Food Safety Consultants, LLC, a consulting firm specializing in food safety and quality program design and training for the international food supply chain. 
“Essentially, FSMA says, ‘Look, given the cost of foodborne illness, it is time that we begin to take the necessary, science-based steps to ensure the food that reaches consumers is safe,’” says Roberts. “The law requires companies that manufacture, distribute and sell foods and beverages to have fully validated and verified block and tackle to ensure their systems are guaranteed to protect the products. By taking a holistic approach to sanitation that integrates prerequisite programs and hygienic controls to ensure these systems are delivering every time, [the sanitation program] becomes easier to manage. Once you get [more effective sanitation programs] in place, opportunities will arise to look at efficiencies.”
There are going to be upfront capital expenditures and training costs, says David Dixon, president, David C. Dixon, LLC, but the costs associated with inaction are what the food industry should avoid. “First, focus on the costs—the largest being the cost due to damage to your brand, the cost of lost sales and customers, the downtime for a plant during cleanup, all the costs to recover from food safety problems,” he says. “Just ask Kellogg’s or others that suffered from Peanut Corporation of America’s problems. These costs run from millions to tens of millions, yet most management executives have no way to factor these potential risks into their hazard analysis when justifying capital investments.”
Knowing your product input costs is a first step toward making peace with the necessary food protection expenditures FSMA will inevitably require of food businesses, Dixon says. Due to the magic of depreciation, a penny per case spent on building investments, or three cents spent on equipment investments, could save 10 to 20 cents per case in operating costs (see chart on page 94). “The leverage effect that sanitary facilities and equipment have on labor, line efficiency, uptime, utilities costs and safety are rarely well understood,” adds Dixon. “Start the food safety initiative with your CFO, your product cost accounting people and those who can see the overall profit picture. Don’t start with the R&D and plant engineering staff alone.” 

1. Reset the mindset

Atlanta-based GSC Packaging, one of the largest contract packagers of powdered food, drink mixes, supplements and diet products in the nation, is FSMA-ready—although the company did not design or implement its food safety, sanitation and quality standards with the upcoming rulemaking as the catalyst. 
In February 2012, the company moved into a new 100,000-sq.-ft. state-of-the-art food packaging facility, which features 15 production lines, including horizontal form fill seal, vertical form fill seal and stick-pack machines. Since the company designed its sanitation and quality programs to meet pharmaceutical industry standards, it expects to exceed the requirements of HARPC, says GSC Packaging CEO Bob Shapiro. 
“We purchased a building, gutted it and built the plant to our specifications, with an emphasis on designing the facility to facilitate sanitation at the highest level,” Shapiro states. “I am not going to say no expense was spared, but cost was not our main consideration. We started with the quality design and risk analysis, and we did not allow anything to infringe on our commitment to a ‘quality first’ company culture. You can’t just talk it; you have to walk it by doing everything possible within your means and your budget to improve the quality components of your operation.”
Roberts, a former director of global raw material food safety and quality with PepsiCo International, agrees that many food companies that fall under the scope of HARPC will need to reset the corporate mindset. “Particularly in small or mid-sized companies that do not have strong food safety and sanitation systems in place, it will be a challenge to sell CEOs on the programs they see as cost centers, rather than an integral part of business processing operations. It is going to take managers with a new mindset to make the business case for food safety to owners and upper management. What will sell it is the value proposition: We’ve got to make the investments in doing the work to see the costs of not doing it, rather than trying to sell it based solely on the need to comply with FSMA.”

2. Lay a strong sanitation foundation

Under the proposed HARPC regulation, the most significant step processing plants will need to take, especially those operations that do not have HACCP programs in place, is to conduct a thorough hazard analysis. This step will have a direct impact on the processor’s ability to identify appropriate and effective preventive controls for its specific operation. Sanitation controls, for example, may be critical control points (CCPs) in the HACCP plan (i.e., preventive controls) or may be tied to the cGMPs and prerequisite programs.  
According to Ed Forrest, director of operations with GSC Packaging, the company’s risk assessment process as part of its HACCP plan was rigorous and thorough, which resulted in a clear pathway to identifying the appropriate sanitation controls for the facility. “We worked meticulously to identify our processes and product flow charts to assess all aspects of operations that affect our process, down to the very fine point of what risks could cause potential harm to consumers and to ensure we were reducing those risks,” says Forrest. 
“In a food packaging environment, there are all sorts of things that you’ve got to take into consideration—floors, ceilings, dust bins, filtration systems, etc. Those are all part of what we considered when we designed rooms, including how we would be able to access them and get them clean so we ensure we are eliminating any potential risks,” he adds. “Even the compressed air for the equipment is filtered to 2 microns, because that air comes in contact with food surfaces. Even that small detail, whatever comes into contact with food surfaces, has been evaluated, identified, and a control has been put into place.” 

3. Incorporate sanitary equipment and facility design principles

John Butts, vice president of research with Land O’Frost, who created the company’s well-known “Seek & Destroy” program in the early 1990s as a proactive way to find and eliminate foodborne pathogens from the ready-to-eat (RTE) meat plant environment, believes sanitary design of equipment and facilities will become key to successful preventive controls plans. 
“Preventive controls means preventive designs, and sanitary equipment and facility design measures help companies stop fire fighting and save money,” Butts states. “Some equipment is simply uncleanable. The cost to manage or clean uncleanable equipment can be significant, and the consequences of an unsanitary production line or facility can be disastrous. I believe there are going to be significant opportunities for equipment companies to put designs at the forefront in the produce industry and other sectors that fall under the scope of FSMA rules. Sanitary design will become a marketable trait in equipment.”
With mandated HACCP programs and prerequisite programs documented to support HACCP, Butts adds, it is easier to see what you need to prevent to better predict when certain intervention strategies need to take place. There are aspects of sanitary design these programs must address, including whether a plant uses complex equipment that requires disassembly during sanitation, whether equipment in the RTE area requires the application of an effective intervention to eliminate Listeria or if equipment, floors, ceilings or doorways have cracks or crevices that would support microbial growth and survival. 
“When you apply the basic principles of sanitary equipment and facility design to your specific operation,” says Butts, “from establishing barriers and zones of control to ensuring equipment is easily accessible and cleanable, you increase the effectiveness of all of your sanitation activities, which in turn supports efficient plant operations.” 
Dixon agrees, noting that some of the most difficult sanitation-related problems to solve are problematic flow paths inside an existing plan that allow recontamination of cooked or clean product. “You need to consider one-direction flows from dirty to clean, new paths to handle rework, separation walls, separate ventilation zones and repiping underfloor drain systems, as well as renovations to raw materials and packaging warehouses, locker rooms and gowning areas, access controls that can’t be bypassed and so on,” he says. “These costs, in a tired, old plant, are often large enough to force an economic calculation that closes the facility.”

4. Make sanitation training a priority

It’s unclear how the proposed sanitation training provision will play out in terms of defining the certifications and experience or education parameters that will be required under HARPC and the cGMP mandates, but it is clear this training will play a critical role in implementing effective preventive controls. The proposed rule is two-pronged. First, plant staff whose duties include identifying sanitation failures or food contamination will need to “provide a level of competency necessary for production of clean and safe food.” Second, food handlers and supervisors will be required to take training in principles of food protection and proper food handling techniques.
GSC Packaging has instituted an extensive personal hygiene and cleaning training program for employees, but it has gone one step further: Anyone who enters the building has to be trained in personal hygiene. “Sanitation training applies to all outside contractors,” notes Shapiro. “Even the electricians have to be trained, and they are surprised, saying they didn’t know there was a test involved to get the contract. But this is a result of our risk analysis, which indicated that, to meet our sanitary operating standards, we needed to hold everyone moving through the plant to the same standard as plant employees.” 
Butts also recommends that processors include all plant personnel in sanitation training, right down to the maintenance staff. “We know one of the keys for effective control of Listeria in RTE food facilities involves teaching the maintenance staff what to do and how to recognize growth niches when they find them in normal daily operations,” he says. “Not only is a well-trained maintenance staff one of your better defenses for proactive sanitation control, but when they are knowledgeable about sanitary design, maintenance personnel can do a quick in-process repair on a well-designed piece of equipment in a matter of seconds or minutes that often translates into real savings.” 

5. No more lip service: Validate and verify

Validating and verifying process and preventive controls is another important aspect of the proposed rules—concepts that are not unknown to the food industry but that FSMA’s HARPC would now codify. “The principles of validation and verification are not a shocking or new concept to food engineers, but they can be confusing to those on the operations side of a plant,” says Roberts. “The era of using one’s senses to ‘validate and verify’ cleanliness is over.”
Simply put, processes, procedures and preventive controls identified in the HARPC food safety plan need to be validated to demonstrate that, under prescribed conditions, a system is working effectively, and the outcome of that process or procedure is reproducible with a very high degree of confidence. Verification presupposes a system or process has been previously validated and involves the continuous monitoring of the system to ensure the expected outcome is consistently delivered over time. It is imperative that whenever the validated process or procedure is modified, adds Roberts, that the processor revalidates it to ensure the system is still effective.
Keener suggests that when applying the validate-and-verify approach to a given sanitation control protocol, an effective first step is to establish a performance objective, for example, determine to what level you expect a cleaning activity to result in a reduction of bacteria or allergens. Next, find published studies or set up experiments to prove with a high degree of confidence that the procedure consistently yields that result. Once the validation is completed, identify and use appropriate procedures to confirm or verify the critical parameters identified in the validation are being realized.
For instance, if a processor uses a high-intensity pulsed light to decontaminate a food-contact surface and wants to achieve a 5-log reduction of Listeria monocytogenes, a validation experiment could be set up to measure and confirm whether the radiation per unit area and the exposure time are adequate for achieving the desired 5-log reduction of the target microorganism. A verification activity might be swabbing and testing to measure the microbial log of L. mono on the surface, or it might mean checking that the CPU is connected to the pulsed light generator to confirm exposure time.  
“People are still using basic ‘it is visibly clean’ criteria to make decisions about sanitation activities that have potentially very serious public health consequences,” Keener says. “Validate and verify is the right way forward. My advice is to take the time to invest in validation on the front end when bringing in a new procedure, a new method, a new protocol. If companies embrace a true science-based method, there is the promise of improved efficiencies and an improved bottom line down the road.”

The best defense is a good offense

Since industry experts expect the final FSMA preventive controls and cGMP provision rulemaking are likely more than a year away from implementation,  affected food companies, especially mid- and small-sized plants, have an excellent window of opportunity to develop and apply the requisite science-based food safety plans.  
As David Dixon notes, arguably the most important preconditions to assure safe food are a facility and equipment that can be cleaned to a microbiological level. “FSMA does not directly address the concerns of the facility designer, the plant engineer or the equipment specifier. It does not direct you to take swabs of your condenser coils. It does not require you to repair your failing floor coating,” he says. 
“It is up to the food processors to decide how best to achieve that,” Dixon continues. “Don’t wait to see what FSMA might eventually have to say about such specifics. Get started now. FMSA eventually will be the tool available to punish you if you do not.” 

For more information:
David Dixon, David C. Dixon, LLC, 630-272-1677, dcd@davidcdixon.com
Larry Keener, International Product Safety Consultants, LLC, 206-283-2829, lkeener@aol.com
Jerry Roberts, Global Quality and Food Safety Consultants, LLC, 973-631-1421, jerryroberts@optonline.net